This study investigates the efficacy of surfactant application during spontaneous breathing with CPAP in avoiding death and chronic lung disease (CLD) in very immature infants with a gestational age of less than 27 weeks.

Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP

Drug: Curosurf

Surfactant application via a thin endotracheal catheter during spontaneous breathing with CPAP, followed by respiratory support with CPAP

Detailed Description:

80 % of extremely preterm infants with a gestational age of less than 27 completed weeks suffer from severe idiopathic respiratory distress syndrome (IRDS). They are still at high risk of mortality and long term morbidity especially of the lung and the brain. At least death and chronic lung disease (CLD) are related to the need and the duration of mechanical ventilation. Continuous positive airway pressure (CPAP) has been shown to be effective to avoid mechanical ventilation in the treatment of IRDS but it often fails in the most immature infants. Early or prophylactic surfactant application is effective in the treatment of IRDS and is the only causal therapy, but it is usually related to intubation and mechanical ventilation that should be avoided.Therefore to overcome the dilemma between need for mechanical ventilation with surfactant administration on the one hand and surfactant withholding with the use of CPAP on the other hand, a strategy was developed to administer surfactant during spontaneous breathing with CPAP (1). In the proposed prospective randomised controlled trial this strategy shall be compared with the recent gold standard in the therapy of extremely preterm infants with IRDS, that is intubation, mechanical ventilation and surfactant administration. Based on the results of a feasibility (1) study and some clinical observations it is hypothesised that the new approach is superior in avoidance of death and chronic lung disease compared to the recent gold standard.

Eligibility

Ages Eligible for Study:

23 Weeks to 26 Weeks (Child)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

IRDS with Silverman-Score ≥ 5 and / or FiO2 ≥ 0,3

Postnatal age of more than 10 min. and less than 2 hours

Gestational age ≥ 23+0 and < 27+0

Exclusion Criteria:

Primary cardio- pulmonary resuscitation

Prenatally diagnosed severe malformation

No parental consent

Participation in another interventional trial

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00751959

Locations

Germany

Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin

Aschaffenburg, Germany, D-63739

Charité

Berlin, Germany, D-13353

Ruhr University of Bochum, Children's Hospital St. Josef Spital

Bochum, Germany, D-44791

University Hospital, Dept. of Neonatology

Bonn, Germany, D-53113

Kliniken der Stadt Koeln, Kinderkrankenhaus Riehl

Cologne, Germany, 50735

University of Cologne, Clinic for Paediatrics

Cologne, Germany, D-50937

Vestische Kinder- und Jugendklinik

Datteln, Germany, D-45711

University Hospital, Clinic for Paediatrics

Duesseldorf, Germany, D-40225

Asklepios Klinik Barmbek

Hamburg, Germany, D-22291

Hospital of Leverkusen, Dept. of Children's Medicine

Leverkusen, Germany, D-51375

University Hospital of Schleswig-Holstein, Campus Lübeck, Dept. of Children's Medicine